Oncolytics Biotech Inc T.ONC

Alternate Symbol(s): ONCY

Healthcare Biotechnology

Oncolytics Biotech Inc. is a clinical-stage biotechnology company. The Company is focused on developing pelareorep, an intravenously delivered immunotherapeutic agent that activates the innate and adaptive immune systems and weakens tumor defense mechanisms. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype turning cold tumors hot through innate and adaptive immune responses to treat a variety of cancers. This improves the ability of the immune system to fight cancer, making tumors more susceptible to a broad range of oncology treatments. The Company’s primary focus is to advance its programs in hormone receptor-positive / human epidermal growth factor 2- negative (HR+/HER2-) metastatic breast cancer and advanced/metastatic pancreatic ductal adenocarcinoma to registration-enabling clinical studies. In addition, it is exploring opportunities for registrational programs in other gastrointestinal cancers through its GOBLET platform study.

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Oncolytics Biotech Inc > Kirk Look to speak today

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Comment by Noteableon Sep 11, 2024 6:46pm

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RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Kirk Look to speak today

So in response to those who don't own any stock in this company but are obsessed with posting their obscure opinions here ... and as I have already posted .. ..By ONCY beginning the process of enrolling between 180-200 patients in a monotherapy pelareorep + paclitaxel clinical/registration study ONCY speeds up the Accelerated Approval process by demonstrating to the FDA that ONCY is well into the implementation of a well designed clinical study, with FDA agreed upon primary and secondary endpoints, that have resulted in previous Accelerated Approvals, as exemplified by Pfizer's Paloma and Daichii's Destiny successes.

Now there is room for one or two with 2 and potentially 3 registration studies to be pursued both in monotherapy and in combination with other I/O agents. The monotherapy registration study offers ONCY the freedom to operate and removes any restriction for the company to partner with one Big Pharma company or another.

An Accelerated Approval results in the creation of a revenue stream for ONCY and an accretive asset for any Big Pharma acquirer of ONCY. And because of this capital opportunity eventually happening, I think that the latter Big Pharma acquisition will happen sooner than later and well before an Accelerated Approval is even announced.

RE:RE:RE:Kirk Look to speak today

Look said this - " ... What we presented to the FDA was a Phase 2 concept, kind of using the receipe that's been used [before], you know, quite a few times. Ibrance is a good example in HER2 as well as a good example of how a Phase 2 the size of 180-200 patients can be powered in a manner that if you reach cerftain endpoints, that the powering is sufficient to seek accelerated approval with the promise of [the Phase 2 study turning into] a confirmatory study ..."

Kirk Look also said the following - " ... we are on the cusp of the (Bracelet-1) overall survival (OS) data. We will expect that to be announced imminently . ... "

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